BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3201306 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06213
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND THE TRIP WIRE WAS SEPARATED FROM THE HANDLE. THE TRIP WIRE HAD BEEN CUT TO ALLOW THE DEVICE TO BE REMOVED FROM THE SCOPE; THE PROXIMAL END OF THE TRIP WIRE WAS NOT RETURNED. THE HANDLE SLOT IS DEFORMED, INDICATING THE TRIP WIRE HAD BEEN SECURED IN THE HANDLE SLOT. SIX OF THE SEVEN BANDS REMAINED ON THE LIGATOR HEAD; FOUR WERE PARTIALLY DEPLOYED. THE LIGATOR HEAD TEETH WERE DAMAGED. IF SLACK WAS PRESENT IN THE TRIPWIRE DURING THE PROCEDURE, IT COULD CAUSE THE THREAD TO MOVE OVER THE LIGATOR TEETH WITHOUT DEPLOYING THE BANDS PROPERLY AND DAMAGING THE LIGATOR HEAD TEETH, AS FOUND WITH THIS DEVICE. IT CANNOT BE CONFIRMED THAT THE TRIP WIRE WAS NOT SECURED PROPERLY DURING USE; THEREFORE, THE MOST PROBABLE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A PROCEDURE TO STOP BLEEDING PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BANDS WOULD NOT DEPLOY DURING THE PROCEDURE. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO STOP THE BLEEDING, AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A PROCEDURE TO STOP BLEEDING PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE BANDS WOULD NOT DEPLOY DURING THE PROCEDURE. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO STOP THE BLEEDING, AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301476 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 0015681738

    Patients

    Seq Age Sex Outcome Treatment
    1